STANDARD FOR THE EUROPEAN QUALITY MANAGEMENT SYSTEM

Transcription

1 STANDARD FOR THE EUROPEAN QUALITY MANAGEMENT SYSTEM A Common Quality Framework for the European Patent Office and the National Patent Offices of the Member States of the European Patent Organisation STANDARD FOR THE EUROPEAN QUALITY MANAGEMENT SYSTEM DRAFTED BY THE EQS WORKING PARTY January

2 Preamble This document sets out a standard for a European Quality Management System (EQMS) which aims to provide a foundation for the patent offices participating in the European Patent Network (EPN) - the European Patent Office (EPO) and National Patent Offices of the Member States of the European Patent Organisation (NPOs) - to achieve convergence and continuous improvement in the quality of their products and services. This document defines the mtnimum requirements of the EQMS that each participating office shall implement within the framework of the EPN as a first step to a European Quality System (EQS). It sets out basic requirements with regard to: 1. Leadership and Policy 2. Management of Resources 3. Management of Administrative Workload 4. Quality Assurance 5. Two-way Communication between Offices and their respective Users 6. Internal Review Mechanisms (based on Quality Data) 7. Independent Review Mechanism 8. Inter-Office Communication 9. Documentation 10. Extent of Information on the Search Process 11. Mtnimum Requirements on the Standards of the Search Results In the following text, "the office" refers to all offices implementing the current standard. 2

3 SECTION 1: LEADERSHIP AND POLICY Top management of the office is responsible for the development and implementation of a Quality Management System (QMS) and for ensuring its compatibility with the EQMS requirements. Top management shall establish a quality policy and ensure the effectiveness of the QMS. It shall ensure that the process of continual improvement progresses. It shall delegate responsibilities for the QMS and document these in an organisational chart. Top management of the office shall communicate to its staff the importance of meeting statutory and regulatory requirements including those of this standard. Top management of the office shall conduct management reviews and ensure the availability of appropriate resources. It shall regularly review quality objectives and ensure that they are communicated and understood throughout the respective office. Top Management of the office shall support the European Patent Network by maintaining appropriate links with each other participating office in order to allow for an exchange of experiences within the EPN and to promote best practice amongst all participating offices. 3

4 SECTION 2: MANAGEMENT OF RESOURCES The office shall be able to accommodate changes in workioad and shall have an appropriate infrastructure to support the search and examination process and to enable staff to comply with instructions. The office shall establish the following resources and infrastructure: 1. A system for continuously monitoring and identifying the resources required to deal with workioad; 2. A quantity of examiners sufficient to deal with the inflow of work each with a diploma of completed studies at university level or -in exceptional casesequivalent professional experience; 3. An effective training and development program for all examiners to ensure that they acquire and maintain the necessary experience and skills and are fully aware of the importance of following work procedures accurately and consistently; 4. Appropriately trained and skilled administrative staff to support the examiners and facilttate the work done in the office; 5. Comprehensive and up-to-date work instructions to help staff understand and adhere to work procedures accurately and consistently; 6. Appropriate equipment and facilities, such as IT hardware and software, to support the work done in the respective office; 7. Access to appropriate search documentation properly arranged for search and examination purposes. 4

5 SECTION 3: MANAGEMENT OF ADMINISTRATIVE WORKLOAD The office shall have in place the following mtnimum practices and procedures for handiing search and examination requests and performing related functions such as data-entry and classification: 1. Effective control mechanisms regarding timely issue of search and examination reports to a quality standard as set by the respective office; and 2. Appropriate control mechanisms regarding fluctuations in demand and backlog management. 5

6 SECTION4: QUALITY ASSURANCE The office shall have quality assurance procedures which ensure timely issue of the products it offers (such as search and examination reports) compliant with documented work procedures and instructions to all staff. Such procedures shall include: 1. An effective internal quality assurance system for assessment, involving verification, validation and monitoring of products (e.g. searches and examination work) for compliance with instructions to staff and channelling feedback to them; 2. A system for verifying the effectiveness of actions taken to address deficiencies and to prevent issues from recurring; and 3. An effective system for ensuring the continuous improvement of the established processes 6

7 SECTION 5: TWO-WAY COMMUNICATION BETWEEN OFFICES AND THEIR RESPECTIVE USERS The office shall have in place a system for measuring, monitoring and using customerfeedback including at least the following elements: 1. An appropriate system for handling complaints and making corrections, and taking corrective and/or preventive action where appropriate and offering feedback to users 2. A procedure for measuring and monitoring user satisfaction and perception and for ensuring their legitimate needs and expectations are met. The office shall make its goals in terms of quality publicly available for the users. 7

8 SECTION 6: INTERNAL REVIEW MECHANISM BASED ON QUALITY DATA Top management of the office shall ensure that a review of the office's QMS is undertaken at planned intervals to ensure the QMS continuing suitability, adequacy and effectiveness. The internal review arrangements shall determine the extent to which the office has established its QMS based on the EQMS requirements and the extent to which it is complying with said requirements. The reviews shall be objective and transparent so as to demónstrate whether or not said requirements are being applied consistently and effectively and shall be undertaken at least once a year. The input to each review shall include information on: 1. Conformity with the office's QMS requirements; 2. Conformity with the EQMS requirements; 3. The effectiveness of the office's QMS itself and its processes; 4. Any corrective and/or preventative action taken to elimtnate any cause of non-compliance; 5. Any follow-up action from previous reviews; 6. Feedback from and to users; 7. Feedback from other offices; 8. Recommendations for improvement; 9. Relevant decisions of national courts and Boards of Appeal, where appropriate. The output from the internal review mechanism shall be analysed by the office to determine to what extent the office's QMS requirements and to what extent the EQMS requirements are being met. The results of the internal review shall be presented to top management within the office so that it can gain an objective appreciation of performance against the office's QMS and the EQMS requirements, and identify opportunities for improvement and where changes are needed. 8

9 SECTION 7: INDEPENDENT REVIEW MECHANISM The office shall submit an initial report to an EQS Quality Body, describing what it has done to implement a QMS based on the requirements set out in this standard. This will help identify and disseminate best practice among offices. After the initial report, the office shall arrange a QMS audit by an independent auditor at planned intervals defined by the EQS Quality Body to determine whether its quality management system: 1. Conforms to the requirements of the EQMS; 2. Is effectively implemented and maintained, and 3. Ensures that lessons learned are identified and actions are taken for continuous improvement. The results of the QMS audit shall be reported to the EQS Quality Body without delay immediately after the review. The EQS Quality Body will report annually to the Administrative Council of the European Patent Organisation. 9

10 SECTION 8: INTER-OFFICE COMMUNICATION To help identify and disseminate best practice among offices and foster continual improvement, the office shall provide for effective communication with other participating offices to allow for prompt feedback from them so that potential systemic issues can be evaluated and addressed. The office shall nomtnate and make known to other participating offices the ñame of a quality contact person. 10

11 SECTION 9: DOCUMENTATION The QMS of the office needs to be clearly described and implemented so that all processes in the office and the resulting products and services can be monitored, controlled, and checked for conformity. Therefore, the office shall provide a reference for its staff and management in the form of a Quality Manual, which documents all the procedures and processes affecting the quality of work, such as classif catión, search, examination and related administrative work. In the manual it is to be indicated where instructions on the procedures to be followed may be found. The following items are considered to be the minimum content for a Quality Manual: 1. The quality policy of the office including a clear statement of commitment to the QMS from top management; 2. The scope of the QMS, including details of and justification for any exclusions; 3. The organisational structure of the office and the responsibilities of each of its departments; 4. The documented processes carried out in the office such as receipt of incoming applications, classification, distribution, search, examination, publication and support processes, and procedures established for the QMS, or references to them; 5. The resources available for carrying out the processes and implementing the procedures; and 6. A description of the interaction between the processes and the procedures of the QMS. 11

12 It is necessary that the following records are kept: 1. A definition of which documents are kept and where they are kept 2. Results of management review; 3. Training, skills and experience of personnel; 4. Evidence of conformity of processes, resulting products and services in terms of quality standards; 5. Results of reviews of requirements relating to products; 6. Evaluations of suppliers; 7. The search and examination processes carried out on each application; 8. Data allowing individual work to be tracked and traced; 9. Records of QMS audits; 10. Authorisation of reléase of product; 11. Actions taken re. non-conforming product, e.g. correction; 12. Actions taken re. corrective action; and 13. Actions taken re. preventative action 12

13 SECTION 10: EXTENT OF INFORMATION ON THE SEARCH PROCESS For internal purposes the office shall document its search process including at least: 1. The databases consulted (patent and non patent literature); 2. The keywords, combinations of words and truncations used; 3. The language(s) in which the search was carried out; 4. The classes and class combinations searched, at least according to the IPC; and 5. A listing of all search statements used in the databases consulted. Each office shall further document for internal purposes special cases such as: 1. Limitation of search and its justification; 2. Lack of clarity of the claims; and 3. Lack of unity. 13

14 SECTION 11: MTNIMUM REQUIREMENTS OF THE STANDARDS OF THE SEARCH RESULTS The office shall present its search result in a format including at least: 1. The application number; 2. The classification (IPC) of the invention and classification where the search was carried out according to Section 504 of the Administrative Instructions under the Patent Cooperation Treaty; 3. The cited documents; and 4. A clear indication of which passages in the cited documents are relevant for which claims, in accordance with or at least equivalent to sections 505 to 508 of the Administrative Instructions under the Patent Cooperation Treaty. 14